2 July 2020
The Therapeutic Goods Amendment (2020 Measures No. 1) Bill 2020,(opens in a new window) which amends the Therapeutic Goods Act 1989 was passed by both houses on 25 June. This amendment introduces a mechanism to protect new research data for low risk complementary medicines that have proven novel efficacy claims. This represents regulatory innovation that the sector has been striving to achieve for many years. The usual intellectual property patenting process is not as readily amenable to protect research investment for ingredients that are already in the public domain.
The new scheme for listed assessed complementary medicines will be similar to the scheme that is already in operation for prescription medicines in the Therapeutic Goods Act. The new regime is designed to provide incentives for sponsors of listed assessed medicines to innovate and undertake the required research to demonstrate the efficacy of their products and facilitate applications for new clinical indications.
Whilst there are several issues around implementation of the new scheme that will be further finessed, this scheme is a very significant step forward for the Australian industry and export potentials, but especially for clinicians and consumers who will benefit from a long awaited step up in research investment in complementary medicines.
“This extraordinary regulatory reform represents one of the most exciting improvements in the complementary medicine landscape that we have witnessed in decades," said Professor Alan Bensoussan, Director, NICM Health Research Institute.
"Advocated and supported by the Complementary Medicines Association, Consumer Healthcare Products Australia and NICM Health Research Institute, this scheme will provide enhanced incentives for research and innovation, and further improve the competitiveness of the industry."